Author: Ron Winslow

The Cleveland Clinic’s Steven Nissen took aim at tight ties between professional medical groups and Big Pharma today and came away with a bit of a red face over a red dress.

Here’s the tale: During a session at the American College of Cardiology, Cardiologist Nissen charged that the American Heart Association issued a tepid statement on a study linking a prediabetes condition called metabolic syndrome with consumption of sugar-sweetened beverages such as those from Coca-Cola. The reason, he said, was Coke’s participation in the heart group’s red-dress campaign (see the logo above), intended to raise awareness about heart disease in women. The logo is currently on many cans of Diet Coke.

“You can’t take the money and be independent,” Nissen said.

Trouble is, while the heart association’s Go Red for Women campaign uses a red dress, it isn’t linked with Coke. The red-dress campaign Nissen was thinking about is run by the government’s National Heart, Lung and Blood Institute, and Diet Coke helps sponsor it.

The heart association doesn’t take any money from Coca-Cola, Clyde Yancy, a Baylor cardiologist and AHA president, told the Health Blog. “The assertion that a scientific statement from the AHA has been [influenced] by a corporate relationship is totally disqualified,” Yancy said.

Oh, well. Nissen, a past president of the ACC, also faulted the cardiology college for granting continuing medical education credits to docs attending a Merck-sponsored seminar where an experimental Merck drug was discussed. Four speakers at the seminar were consultants for Merck. The drug eventually failed a late stage trial and wasn’t approved. Nissen called the program marketing, not education.

A Merck doc took issue with that description, but ACC’s CEO Jack Lewin considered it close to the mark. “That is wrong. It shouldn’t happen,” he told the Associated Press. “We can do better than that.” The ACC has taken strong steps to curb industry influence in physician education.

Nissen has long faulted industry funding for medical groups. And he has oftenbeen right in taking on industry on drug-safety issues going back several years.

Image: The Heart Truth logo is a trademark of HHS

“In evaluating an anticoagulant,” says heart researcher Michael Ezekowitz, “it’s all about getting the dose right.”

That’s the next big challenge for Merck and its partner Portola as they prepare to advance the closely held South San Francisco biotech’s drug betrixaban into a large-scale clinical trial in the burgeoning race to develop a replacement for the heart drug warfarin.

Ezekowitz, a cardiologist at Lankenau Institute for Medical Research, Wynnewood, Pa., told a packed auditorium at the annual science meeting of the American College of Cardiology on Monday that a daily 40-milligram dose of betrixaban caused significantly fewer cases of major or clinically important bleeding than standard treatment with warfarin. Bleeding rates were similiar to warfarin at 60 and 80 milligrams, said Ezekowitz, who led the study. Side affects included diarrhea and nausea.

The Phase 2 study tested the medicine in patients with atrial fibrillation, a heart rhythm disorder that afflicts some 2.5 million Americans and carries the risk of blood clots that can lead to a stroke.

Warfarin, a half-century old workhorse anticoagulant from Bristol-Myers Squibb and generic companies, effectively prevents such clots. But patients need regular blood checks and frequent dose changes to prevent life-threatening clots or bleeding episodes.

After decades of frustration in the hunt for an effective alternative that doesn’t require monitoring, the pipeline is now full of promise. Boehringer Ingleheim, Daiichi Sankyo and joint ventures between Pfizer and Bristol-Myers and Johnson & Johnson and Bayer all have compounds in development for a global market that some analysts expect will exceed $10 billion by later in the decade.

Merck and Portola trail most of their rivals at the moment, but they believe features of its compound, including once-daily dosing and the fact that Portola is developing an antitode that could quickly turn the drug off in the event of a dangerous bleed, could be advantages for betrixaban if it reaches the market.

First they have to find the dose that hits the sweet spot between too much clotting and too much bleeding. Will a 40-milligram dose with the favorable bleeding risk be strong enough to effectively prevent clots? That’s one big question Merck and Portola will ponder in the months ahead as they plan a trial they hope will lead to the drug’s approval.

Bill Lis, Portola’s new CEO, indicated one possibility is to move more than one dose into a Phase 3 trial. “It’s clear we have an active drug that is safe and tolerable and ready for the next stage of development,” Lis says.

Photo by CarbonNYC via Flickr

Boston Scientific is back in the regulatory doghouse after the medical-device maker failed to report to the FDA changes in how it manufactures its line of implantable heart defibrillators

The company has recalled the devices and halted further shipments until it resolves the reporting issue with the FDA. The business accounts for 15% of its revenue, which totaled $8.19 billion in 2009. Sanford Bernstein analyst Derrick Sung, tells the WSJ’s Jonathan Rockoff the sales suspension will cost the company $5 million a day.

In addition to the financial hit, the news is another black-eye for the Natick, Mass., company, which has struggled with quality control and other regulatory issues over much of the past decade. In January 2006, the FDA cited Boston Scientific for “ongoing systemic” quality control problems that included manufacturing concerns about its Taxus drug-coated stent.

That was about the same time the company beat out Johnson & Johnson in a bitter takeover battle for Guidant. In addition to Guidant’s implantable heart rhythm device business, Boston Scientific acquired a host of that company’s quality issues in the deal. Among other things, the FDA refused to approve several important new products until Boston Scientific cleaned up the problems.

Recently, Boston Scientific “has been in the process of rebuilding its reputation,” Doug Zipes, a heart rhythm disorder specialist and past president of the American College of Cardiology, tells the Health Blog at the college’s annual scientific meeting in Atlanta.

Zipes says the news that the company is halting sales of all of its implantable heart rhythm devices “strikes me as an overreaction” to “what appears to be a bookkeeping error with the FDA.”

Boston Scientific says in a statement it brought the new reporting problem to the FDA’s attention and “has no inidcation that the manufacturing process changes pose any risk to patient safety.” It isn’t recommending that any patient have devices removed. The company says it is working closely with regulators “to resolve this situation as soon as possible.”

“This isn’t going to affect patient care,” Zipes says. “We have alternative devices” from Boston Scientific rivals such as Metronic and St. Jude Medical, whose stocks rose smartly today as Boston Scientific’s sank on the news. “I see this as more of a problem for Boston Scientific than for the medical community.”